510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Anti-Stick Glass Syringe
Unknown
The Anti-Stick Glass Syringe is a single-use accessory device intended for use with sterile 1 mL long staked needle prefilled ISO standard glass syringes to protect healthcare professionals, patients who self-inject, and their assistants from accidental needlestick injuries. It is classified as "Not Classified" (Class N) by the FDA, meaning it has not been assigned to an established classification and requires further regulatory determination. The product code is PGO, reviewed by the General Hospital (HO) panel. This device is applicable to a wide patient range including children and adults.
No 510(k) clearances found for "PGO". Try a different K-number, product code, or device name.
What is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.